Multidisciplinary Research Into the Effects of Resistance Exercise and Whey Protein Supplementation in Healthy Older Men

NCT ID: NCT03299972

Last Updated: 2019-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-27

Study Completion Date

2019-06-30

Brief Summary

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The aim of this randomised, double-blind, placebo-controlled, parallel groups trial is to investigate the effects of 12 weeks resistance exercise and whey protein supplementation on energy metabolism, markers of appetite, inflammation and hormonal response and body composition and strength and functional performance.

Generally healthy, retired men aged 60-80 years will be recruited (n = 52 in total, n = 13 per group). Participants will be randomised to either: a) control group, b) whey protein supplement group, c) resistance exercise + control group or d) resistance exercise + whey protein supplementation group.

Detailed Description

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With demographics indicating that the world's population aged \>60 years will increase from 600 million reported in 2000, to \>2 billion by 2050, there is an increasing interest in health issues related to ageing. One area of particular interest is sarcopenia, defined as the progressive loss of muscle mass, strength and physical function as a consequence of ageing. Sarcopenia has been associated with an increase in cardiovascular disease, poor metabolic and cognitive function, reduced quality of life and early mortality. Studies have reported beneficial effects of both resistance exercise and increasing protein intake independently and in combination on markers of sarcopenia (mostly increases in muscle mass, strength and physical function). However, little is known about the effects of combined intervention on energy metabolism, appetite and cognitive and endocrine function. This randomised, double-blind, placebo-controlled, parallel groups trial will investigate these, alongside assessing the effects of combined intervention on total lean tissue mass, muscular strength and functional performance.

Conditions

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Sarcopenia Muscle Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

23.75 g maltodextrin twice daily (breakfast and lunch)

Whey Protein

Group Type EXPERIMENTAL

Whey Protein

Intervention Type DIETARY_SUPPLEMENT

25 g whey protein supplementation twice daily (breakfast and lunch)

Resistance Exercise + Control

Group Type EXPERIMENTAL

Control

Intervention Type DIETARY_SUPPLEMENT

23.75 g maltodextrin twice daily (breakfast and lunch)

Resistance Exercise

Intervention Type OTHER

60 minutes of resistance exercise twice a week

Resistance Exercise + Whey Protein

Group Type EXPERIMENTAL

Whey Protein

Intervention Type DIETARY_SUPPLEMENT

25 g whey protein supplementation twice daily (breakfast and lunch)

Resistance Exercise

Intervention Type OTHER

60 minutes of resistance exercise twice a week

Interventions

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Whey Protein

25 g whey protein supplementation twice daily (breakfast and lunch)

Intervention Type DIETARY_SUPPLEMENT

Control

23.75 g maltodextrin twice daily (breakfast and lunch)

Intervention Type DIETARY_SUPPLEMENT

Resistance Exercise

60 minutes of resistance exercise twice a week

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Retired Men aged 60-80 years
* Body Mass Index 18.5-30 kg/m2
* Not participated in resistance exercise within the last 6 months
* Free from musculoskeletal injury

Exclusion Criteria

* Retired Men aged \<60 or \>80 years
* Current smokers, or ex-smokers ceasing \<6 months ago
* Body Mass Index \<18.5 and \>30 kg/m2
* Currently participating in resistance exercise regularly (within last 6 months)
* Not weight stable and/or looking to start a weight loss programme
* Individuals participating in another research project (within the last 6 months) involving dietary and/or exercise intervention
* Existing or past medical history of vascular disease, cancer, diabetes, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, osteoporosis or history of falls
* Currently taking protein/amino acid supplements regularly
* Currently prescribed non-steroidal anti-inflammatory medication, hormone replacement therapy (HRT), diabetic medication, beta-blockers, statins
* Uncontrolled blood pressure (Blood pressure \>160/100 mmHg)
* Self-reported lactose intolerant or allergic to wheat or potatoes
* Individuals with a pacemaker
* Neuromuscular disorders or injuries
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role collaborator

Coventry University

OTHER

Sponsor Role lead

Responsible Party

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Corbin Griffen

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derek Renshaw, PhD

Role: STUDY_DIRECTOR

Coventry University

John Hattersley, PhD

Role: STUDY_DIRECTOR

University Hosptials Coventry and Warwickshire NHS Trust

Michael Duncan, PhD

Role: STUDY_DIRECTOR

Coventry University

Corbin Griffen, MSc

Role: PRINCIPAL_INVESTIGATOR

Coventry University

Locations

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Coventry University

Coventry, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

References

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Griffen C, Renshaw D, Duncan M, Weickert MO, Hattersley J. Changes in 24-h energy expenditure, substrate oxidation, and body composition following resistance exercise and a high protein diet via whey protein supplementation in healthy older men. Physiol Rep. 2022 Jun;10(11):e15268. doi: 10.14814/phy2.15268.

Reference Type DERIVED
PMID: 37815091 (View on PubMed)

Griffen C, Duncan M, Hattersley J, Weickert MO, Dallaway A, Renshaw D. Effects of resistance exercise and whey protein supplementation on skeletal muscle strength, mass, physical function, and hormonal and inflammatory biomarkers in healthy active older men: a randomised, double-blind, placebo-controlled trial. Exp Gerontol. 2022 Feb;158:111651. doi: 10.1016/j.exger.2021.111651. Epub 2021 Dec 9.

Reference Type DERIVED
PMID: 34896568 (View on PubMed)

Other Identifiers

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P59723

Identifier Type: -

Identifier Source: org_study_id

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